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Efficacy and safety of glucocorticoids in the treatment of severe community-acquired pneumonia in adults: a multicenter, randomized, primary care, placebo-controlled, parallel clinical study

Efficacy and safety of glucocorticoids in the treatment of severe community-acquired pneumonia in adults: a multicenter, randomized, primary care, placebo-controlled, parallel clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098654
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-03-12
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe community-acquired pneumonia

Interventions

Placebo group:Intravenous saline
Experimental group:Intravenous methylprednisolone sodium succinate

Sponsors

Second Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.>=18 years old; 2.Admitted to ICU; 3.Diagnosis of severe community-acquired pneumonia Community-acquired pneumonia can be diagnosed as severe pneumonia if one of the following primary criteria or >=3 secondary criteria are met: Main criteria: (1) Mechanical ventilation is required for tracheal intubation; (2) Septic shock still requires vasoactive drug therapy after active fluid resuscitation. Secondary criteria: (1) Respiratory rate > 30 times /min; (2) Oxygenation index 7.14mmol/L; (6) Systolic blood pressure < 90mmHg requires active fluid resuscitation; 4.Patients or clients sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Clinical history suggests aspiration of gastric contents; 2.The patient received invasive mechanical ventilation within 14 days before admission; 3.Patients who have been treated with antibiotics for respiratory infections for more than 5 days at admission (unless resistance to the antibiotic is isolated) Diseased body); 4.Patients with active tuberculosis or fungal infection, active viral hepatitis, or active herpes virus infection; 5.Patients who need glucocorticoids for any other reason; 6.Patients receiving more than 15mg/ day of prednisone (or equivalent) for more than 30 days.

Design outcomes

Primary

MeasureTime frame
28-day survival rate;

Secondary

MeasureTime frame
90-day survival rate;

Countries

China

Contacts

Public ContactLuo Hong

Second Xiangya Hospital, Central South University

luohong1003@163.com+86 731 85292097

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026